Cancer is uncontrolled growth of new tissue, which is caused by degeneration of endogenic cells. Cancer cells are capable of invading other tissues and can destroy the latter. The main groups of cancerous diseases or tumor diseases include sarcomas, carcinomas, leukemias and lymphomas. The most frequent causes of death in industrial societies include cancerous and tumor diseases. For this reason, there have been great efforts of developing therapies for the treatment of cancerous diseases. However, many of these methods of treatment have been successful only in part. On the one hand, a tumor having already established in the body is difficult to combat in an organism by means of well-known agents, and, on the other hand, the antitumor agents being used generally show a large number of undesirable side effects, limiting in particular the dosage of agents to be administered.
In addition to gene-therapeutic approaches for the treatment of cancerous diseases, selected metals or metal compounds, e.g. of vanadium, molybdenum, gold and, in particular, platinum, have been used in the treatment of various tumor diseases for years. Apart from general side effects, a large number of the above-mentioned compounds being employed, e.g. platinum compounds, have a high toxic potential, and more specifically, these compounds are nephrotoxic. Furthermore, platinum compounds such as cis-platinum compounds show specific undesirable side effects, e.g. severe diarrhea, serious vomiting, loss of body hair, especially hair of the head. Furthermore, the activity—especially the immunologic activity—of the bone marrow is suppressed.
As a result of all this, patients—despite the threatening disease they experience—would prematurely break off this type of therapy and select other forms of therapy in order to treat their pathogenic condition.
As can be seen in cancer therapies in total, patients to be treated approve orally administered agents. An oral chemotherapy, for example, is very well accepted by patients owing to the fact that normal life can be continued, and that such treatments show relatively few side effects. In 2001, about 25 to 30% of the medications used in oncology were oral formulations. These oral formulations are conditionally suitable for the treatment of various disease-related mechanisms. Well-known examples of oral antitumor therapies are e.g. administration of cytotoxic agents, anti-angiogenesis products, agents modifying the cell cycle mechanisms, inhibitors of signal transduction, and hormone suppressants.
As a result of said good acceptance of oral chemotherapeutic agents, a number of attempts have been made in the prior art in order to provide pharmaceutical agents to be applied on the oral route, which would have good antitumor activity in combination with low toxicity. For this reason, there have been a number of attempts of providing pharmaceutical agents based on molybdenum, vanadium, gold, and especially platinum components, which have effective activity and few side effects. Well-known chemotherapeutic agents are highly toxic, therefore involving some risk in handling during shipping, delivery and storage.
A number of oxoplatinum (cis-oxoplatinum) compounds are well-known as tumor-influencing agents, comprising e.g. cis-diammoniumdichloro-trans-dihydroxoplatinum(IV) in buffer or NaCl solutions, which are applied in laboratory animals. There are no or few disclosures in the prior art as to pharmaceutical-technical formulations that could be used in humans. As is well-known, the pharmaceutical-technical formulation has an influence on the effect in human or animal patients. The prior art fails to provide data on particular compositions of pharmaceutical-technical base materials enabling effective activity of cis-oxoplatinum in living organisms.
To date, there has been no success in providing pharmaceutical agents to be used orally, especially chemotherapeutically usable compounds based on platinum compounds, which have low toxic activity, especially nephrotoxic activity. Furthermore, it has not been possible as yet to develop pharmaceutical agents comprising platinum, which could be accepted by patients and could be used e.g. as creams or ointments, especially for the treatment of tumor diseases of the skin.
The object of the invention was therefore to provide chemotherapeutical agents in a form that would not have the above-mentioned drawbacks, the oxoplatinum compound being used having low toxicity, especially nephrotoxicity, being well suited for use as oral agent or as a cream or ointment in tumor therapy, said oxoplatinum compound being incorporated in a well-defined pharmaceutical-technical formulation which allows safe and efficient effect of the oxoplatinum as a chemotherapeutical agent.